Safety-verification trial about excessive intake of test beverage
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000041259
- Lead Sponsor
- CPCC Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 16
Not provided
(1) Subjects with some kind of continuous medical treatment. (2) Subjects with current and/or previous medical history of serious diseases in heart, liver, kidney and/or digestive organs. (3) Subjects who have constantly used the following foods that might affect their blood glucose level, triglyceride level, and intestine-regulating function; health-specific, functional, health foods. (4) Subjects with excessive alcohol intake. (5) Subjects with extremely irregular dietary habits and/or life rhythm. (6) Pregnant or possibly pregnant women, or lactating ones. (7) Subjects with drug and/or food allergy (especially in milk and soybean). (8) Subjects with weak stomach and/or diarrhea-prone constitution. (9) Subjects who are now under the other clinical tests with some kind of medicine/food, or participated those tests within four weeks after this clinical trial. (10) Subjects who donated over 200 mL of their blood and/or blood components within a month to this clinical trial. (11) Males who donated their whole blood (400 mL) within the last three months to this trial. (12) Females who donated their whole blood (400 mL) within the last four months to this trial. (13) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (14) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial. (15) Others who have been determined as ineligible for participation in this trial, according to the principal/sub investigator's opinions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence rates of some kind of adverse event and/or side effect
- Secondary Outcome Measures
Name Time Method 1. Physical measurement 2. Physiological test 3. Hematological test 4. Blood-biochemical test 5. General urinalysis